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Sterilization process indicator, chemical/enzymatic

Access comprehensive regulatory information for Sterilization process indicator, chemical/enzymatic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Sigma Company Limited, manufactured by Medipack Medical Packaging Mfg Co (Taiwan) in Taiwan. The device registration started on February 13, 2008.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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TGA ARTG Official Data
Class I
Class I
Sterilization process indicator, chemical/enzymatic
Australia TGA ARTG Registered Device
Good Name: Sigma Company Limited- Sterilization process indicator, chemical/enzymatic
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Intended Purpose

An enzyme coated strip or tape that changes colour when exposed to an effective sterilization outcome indicating that sterilization parameters have been met

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 13, 2008
Effective Date
February 13, 2008
Manufacturer
Country
Taiwan
Address
13 Lin Kuo 4th Industrial Park, Tin Hu Road, Guei Shan Hsiang, Tao Yuan Hsien, 333